Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation

Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies have indicated patients prefer autoinjectors to other injection methods, however, patients must be able to demonstrate safe and effective use of an autoinjector for it to be a viable option. The YLB113 etanercept autoinjector may be a substitutable biosimilar to reference etanercept (Pfizer Manufacturing, Puurs, Belgium). This study sought to confirm intended users of the YLB113 etanercept autoinjector could demonstrate safe and effective use. Methods: The evaluation was performed among 79 participants representative of intended YLB113 etanercept autoinjector users; and included patients, caregivers and healthcare providers (HCPs). Results: All participants successfully delivered two simulated doses of etanercept into the foam pad using the autoinjector. Some participants experienced user errors, use difficulties, or close calls while simulating injection or answering knowledge questions. Discussion: In this usability evaluation, study patients, caregivers and HCPs demonstrated a high rate of injection success using the YLB113 etanercept autoinjector. Conclusions: The study results support demonstration of safe and effective use of the YLB113 etanercept autoinjector, a substitutable biosimilar to reference etanercept.